Software QA EngineerLocation: Dublin (Hybrid – e.g., 3 days per week on site/2 days per week remote)Job PurposeThe Software QA Engineer will support quality and compliance activities associated with software and drive the execution of related objectives.ResponsibilitiesParticipate in cross-functional product development and provide practical QA and Design Assurance expertise, in particular related to software design and development, verification and validation, risk management, manufacture, and control.Drive software quality assurance process optimisation and improvements, as needed, to ensure that all software quality systems remain fit for purpose and satisfy all customer requirements.Collaborate with the wider team to ensure that necessary and sufficient QA activities are planned, executed, and recorded.Ensure computer system validation (CSV) processes are in place and followed.Manage suppliers to support quality assurance of product software and assessment/validation of QMS software.Engage with the QMS and the organisation to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives.Other ad-hoc duties as required.Experience & EducationEssentialBachelor’s Degree in Engineering, Science or software-related field3+ years’ experience in medical device quality/design assurance role with focus on medical device software (or similar regulated industry such as pharmaceuticals)Strong knowledge of the software development lifecycle (i.e. IEC62304)Recent regulatory experience including FDA regulations, Medical Device Regulation (MDR) and other applicable national and international regulations and StandardsDesirableExperience with cybersecurity requirements for medical device softwareExperience in implantable medical devicesExperience with medical electrical equipmentExperience with clinical investigations of medical devicesExperience with Jira or equivalent software development lifecycle toolingSkillsDemonstrated proficiency in technical design documentation and software development lifecycle processes/toolsStrong communication and influencing skills – good listenerAbility to work under pressure and meet deadlinesAbility to manage multiple projects and deadlinesTarget-driven individual who can work on their own initiativeStrong analytical and problem-solving abilitiesAbility to make decisions and own processesThrives in a fast-paced start-up environmentReportingReports to Software QA Manager
#J-18808-Ljbffr